A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
- Compare the effectiveness, in terms of overall survival, of consolidation therapy with
or without strontium chloride Sr 89 after induction chemotherapy in patients with
androgen-independent prostate cancer.
OUTLINE: This is a randomized study. Patients are stratified according to type of induction
chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20
vs more than 20), ECOG performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).
- Induction therapy: Patients receive 1 of 2 induction therapy regimens.
- Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral
ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive
vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on
days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8.
Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease
progression or unacceptable toxicity.
NOTE: *Patients continue to receive oral ketoconazole three times daily until disease
- Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on
days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment
repeats every 21 days for at least 5 courses in the absence of disease progression or
- Consolidation therapy: Patients with a prostate-specific antigen (PSA) response
(at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA
levels decreased at least 50% from baseline) are randomized to 1 of 2
consolidation treatment arms.
- Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus
strontium chloride Sr 89 IV once at the beginning of chemotherapy.
- Arm II: Patients receive doxorubicin as in arm I. Patients are followed every 4 weeks
until PSA progression and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this
study within 48 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Followed every 4 weeks until PSA progression then every 3 months
Shi-Ming Tu, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Medical City Dallas Hospital||Dallas, Texas 75230|
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|CCOP - Greenville||Greenville, South Carolina 29615|
|Hematology Oncology Associates of the Quad Cities||Bettendorf, Iowa 52722|
|Northern Rockies Radiation Oncology Center||Billings, Montana 59101|
|Hematology-Oncology Centers of the Northern Rockies - Billings||Billings, Montana 59101|
|Big Sky Oncology||Great Falls, Montana 59405|
|St. Peter's Hospital||Helena, Montana 59601|
|Kalispell Regional Medical Center||Kalispell, Montana 59901|
|Glacier Oncology, PLLC||Kalispell, Montana 59901|
|Montana Cancer Center at St. Patrick Hospital and Health Sciences Center||Missoula, Montana 59802|
|Montana Cancer Specialists at Montana Cancer Center||Missoula, Montana 59802|
|Community Medical Center||Missoula, Montana 59801|
|Veterans Affairs Medical Center - Hines||Hines, Illinois 60141|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Swedish-American Regional Cancer Center||Rockford, Illinois 61104-2315|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Genesis Regional Cancer Center at Genesis Medical Center||Davenport, Iowa 52803|
|Welch Cancer Center at Sheridan Memorial Hospital||Sheridan, Wyoming 82801|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Cancer Treatment Center||Wooster, Ohio 44691|
|Billings Clinic - Downtown||Billings, Montana 59107-7000|
|Bozeman Deaconess Cancer Center||Bozeman, Montana 59715|
|St. James Healthcare Cancer Care||Butte, Montana 59701|
|Great Falls Clinic - Main Facility||Great Falls, Montana 59405|
|Sletten Cancer Institute at Benefis Healthcare||Great Falls, Montana 59405|
|Kalispell Medical Oncology at KRMC||Kalispell, Montana 59901|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Barberton Citizens Hospital||Barberton, Ohio 44203|
|Good Samaritan Cancer Center at Good Samaritan Hospital||Kearney, Nebraska 68848-1990|
|Kinston Medical Specialists||Kinston, North Carolina 28501|
|McLeod Regional Medical Center||Florence, South Carolina 29501|
|Great Falls, Montana 59405|
|Guardian Oncology and Center for Wellness||Missoula, Montana 59804|
|St. Vincent Healthcare Cancer Care Services||Billings, Montana 59101|
|Cancer Care Center, Incorporated||Salem, Ohio 44460|